Comment Period on Return of Genetic Testing Results to Close Soon

The FDA’s open comment period on the return of genetic testing results will be closing March 31, 2016.

The FDA recently held a public workshop called “Patient and Medical Professional Perspectives on the Return of Genetic Test Results,” to learn more about the public's and health care providers’ perspectives on how to receive medically relevant genetic test results.

Other topics discussed at the workshop included the specific kind of information patients and providers prefer to receive, the type and amount of evidence available to interpret the results, and what other information is required to understand the results to benefit medical decision making.

Health care providers and the public may submit written comments to the FDA until the end of the month using the following address: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

All submissions must include the docket number: FDA-2015-N-4809.

To comment electronically, providers may go to http://www.regulations.gov.

The public workshop was in response to President Barack Obama’s precision medicine initiative, which was announced on January 20, 2015. The initiative aims to “empower health care providers to tailor treatment and prevention strategies to an individual’s unique characteristics.”

Now, the FDA is considering new approaches to how it regulates Next Generation Sequencing, which can provide an analysis of genetic information.